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SchizophreniaPhase 1NCT07549581

A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode

A Phase 1 study testing SEP-380135 in people with Schizophrenia and Major Depressive Disorder (MDD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD). Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
SEP-380135
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
1 siteUnited States
Study dates
7 Nov 2024to 12 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • BMI from 18.0 to 35.0 kilograms per square meter (kg/m^2) (inclusive).
  • Participants with a primary diagnosis of schizophrenia (cohorts 1 to 3) or bipolar I or II disorder or MDD (cohort 4) for at least 1 year (at screening), as established by clinical review, using the DSM-5 as a reference, and confirmed using the Mini international neuropsychiatric interview (MINI).
  • For cohorts 1 to 3: deemed to have residual symptoms of schizophrenia at screening (i.e., be at least "mildly ill" per CGI-S criteria [CGI-S greater than or equal to (≥) 3]) and a PANSS criteria of less than or equal to (≤) 75. For cohort 4 only: deemed to be currently experiencing an MDE. Participants must be at least "moderately ill" per CGI-S criteria (CGI-S ≥ 4).
  • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the PI, to comply with all the requirements of the trial.

Who cannot join

  • Attempted suicide within 12 months prior to screening
  • A disorder or history of a condition, or previous gastrointestinal conditions that may interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal motility, or pH, or a history of clinically significant abnormality of the hepatic (including participants with moderate [Child-Pugh Class B] and severe [Child-Pugh Class C] hepatic impairment) or renal system (a glomerular filtration rate less than (<) 60 milliliters per minute (mL/min)), or a history of malabsorption, bowel resection, bariatric surgery or gastric band/lap band surgery, or is on medications that might interfere with gastric motility.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin ≥ 2 times the upper limit of the reference ranges provided by the safety laboratory at screening, or total bilirubin ≥ 2 times the upper limit of reference (except for participants with Gilbert's syndrome or similar condition).
  • Has any clinically significant unstable medical condition, clinically significant chronic disease, or any psychiatric symptom or diagnosis that in the opinion of the investigator, MM, or sponsor would pose a risk to the participant or the scientific objectives of the trial.
  • Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720

Other trials in United States

About this study

Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of SEP-380135 in Adults With Schizophrenia or With a Major Depressive Episode Associated With Bipolar I or II Disorder or Major Depressive Disorder

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD).

Being tested
SEP-380135, Placebo
Medical subject headings
Schizophrenia, Depressive Disorder, Major, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEP-380135Drug

    oral capsule.

  • PlaceboDrug

    Placebo capsule.

Study groups in NCT07549581
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants receive SEP-380135 Dose Level 1, orally once daily (QD) from Day 1 to Day 14.
Receives: Drug: SEP-380135
Cohort 2ExperimentalParticipants receive SEP-380135 Dose Level 2 orally once daily (QD) from Day 1 through Day 14.
Receives: Drug: SEP-380135
Cohort 3ExperimentalParticipants receive SEP-380135 Dose Level 3 orally once daily (QD) from Day 1 through Day 14.
Receives: Drug: SEP-380135
Cohort 4ExperimentalParticipants receive SEP-380135 Dose Level 4 orally once daily (QD) from Day 1 through Day 14.
Receives: Drug: SEP-380135
PlaceboPlacebo comparatorParticipants receive SEP-380135 matching-placebo orally orally once daily (QD) from Day 1 to Day 14.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cohorts: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) Leading to Trial Discontinuation

    Measured: Up to Day 44

  2. All Cohorts: Percentage of Participants With Suicidal Ideation or Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: Up to Day 18

  3. All Cohorts: Percentage of Participants With Withdrawal Symptoms Using the 20-Item Physician Withdrawal Checklist (PWC-20)

    Measured: Up to Day 44

  4. All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Laboratory Tests

    Measured: Baseline, Day 18

  5. All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Vital Signs

    Measured: Baseline, Day 18

  6. All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Orthostatic Effects

    Measured: Baseline, Day 18

  7. All Cohorts: Actual Values of Weight

    Measured: Up to Day 18

  8. All Cohorts: Change From Baseline in Weight

    Measured: Baseline, Day 18

  9. All Cohorts: Actual Values of Body Mass Index (BMI)

    Measured: Up to Day 18

  10. All Cohorts: Change From Baseline in BMI

    Measured: Baseline, Day 18

  11. All Cohorts: Actual Values of Waist Circumference

    Measured: Up to Day 18

  12. All Cohorts: Change From Baseline in Waist Circumference

    Measured: Baseline, Day 18

  13. All Cohorts: Percentage of Participants With Change From Baseline in 12-Lead Electrocardiogram (ECG)

    Measured: Baseline, Day 18

  14. All Cohorts: Actual Values of QT interval corrected using Fridericia's Formula (QTcF)

    Measured: Up to Day 18

  15. All Cohorts: Change From Baseline in QTcF

    Measured: Baseline, Day 18

  16. Cohorts 1, 2, and 3: Actual Values of Clinician-Administered Dissociative States Scale (CADSS) Score

    Measured: Up to Day 18

  17. Cohorts 1, 2, and 3: Change From Baseline in CADSS Score

    Measured: Baseline, Day 18

  18. All Cohorts: Actual Values of Drug Effect Questionnaire (DEQ) Scored Using Visual Analog Scale Score

    Measured: Up to Day 18

  19. All Cohorts: Change From Baseline in DEQ Scored Using Visual Analog Scale Score

    Measured: Baseline, Day 18

  20. Cohorts 1, 2, and 3: Actual Values of Barnes Akathisia Rating Scale (BARS) Score

    Measured: Up to Day 18

  21. Cohorts 1, 2, and 3: Change From Baseline in BARS Score

    Measured: Baseline, Day 18

  22. Cohorts 1, 2, and 3: Actual Values of Abnormal Involuntary Movement Scale (AIMS) Score

    Measured: Up to Day 18

  23. Cohorts 1, 2, and 3: Change From Baseline in AIMS Score

    Measured: Baseline, Day 18

  24. Cohorts 1, 2, and 3: Actual Values of Simpson Angus Scale (SAS) Score

    Measured: Up to Day 18

  25. Cohorts 1, 2, and 3: Change From Baseline in SAS Score

    Measured: Baseline, Day 18

  26. Cohorts 1, 2, and 3: Actual Values of Positive and Negative Syndrome Scale (PANSS) Score

    Measured: Up to Day 18

  27. Cohorts 1, 2, and 3: Change From Baseline in PANSS Score

    Measured: Baseline, Day 18

  28. All Cohorts: Actual Values of Clinical Global Impressions-Severity Scale (CGI-S) Score

    Measured: Up to Day 18

  29. All Cohorts: Change From Baseline in CGI-S Score

    Measured: Baseline, Day 18

  30. Cohorts 1, 2, and 3: Actual Values of Calgary Depression Scale for Schizophrenia (CDSS) Score

    Measured: Up to Day 18

  31. Cohorts 1, 2, and 3: Change From Baseline in CDSS Score

    Measured: Baseline, Day 18

  32. All Cohorts: Percentage of Participants With Change From Baseline in Physical Examinations

    Measured: Baseline, Day 18

  33. All Cohorts: Percentage of Participants With Change From Baseline in Neurological Examinations

    Measured: Baseline, Day 18

  34. Cohort 4: Actual Values of Hamilton Anxiety Rating Scale (HAM-A) Score

    Measured: Up to Day 18

  35. Cohort 4: Change From Baseline in HAM-A Score

    Measured: Baseline, Day 18

  36. Cohort 4: Actual Values of Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Measured: Up to Day 18

  37. Cohort 4: Change From Baseline in MADRS Score

    Measured: Baseline, Day 18

  38. Cohort 4: Actual Values of Young Mania Rating Scale (YMRS) Score

    Measured: Up to Day 18

  39. Cohort 4: Change From Baseline in YMRS Score

    Measured: Baseline, Day 18

  40. All Cohorts: Percentage of Participants With Changes in Quantitative Sleep Parameters Measured Using Electroencephalography (EEG)

    Measured: Up to Day 17

  41. All Cohorts: Apparent Clearance (CL/F) of SEP-380135

    Measured: Day 14

  42. All Cohorts: Volume of Distribution (Vz/F) of SEP-380135

    Measured: Day 14

  43. All Cohorts: Maximum Plasma Concentration (Cmax) of SEP-380135

    Measured: Day 14

  44. All Cohorts: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of SEP-380135

    Measured: Day 14

Secondary outcomes (6)

  1. All Cohorts: Cmax of SEP-380135 and its Metabolites

    Measured: Days 1 and 14

  2. All Cohorts: Time to Maximum Plasma Concentration (tmax) of SEP-380135 and its Metabolites

    Measured: Days 1 and 14

  3. All Cohorts: AUC0-24h of SEP-380135 and its Metabolites

    Measured: Days 1 and 14

  4. All Cohorts: Observed Plasma Concentration at 24 hours Postdose (C24h) of SEP-380135

    Measured: Days 1 and 14

  5. All Cohorts: Terminal Phase Elimination Half-Life (t1/2,z) of SEP-380135 and its Metabolites

    Measured: Day 14

  6. All Cohorts: Serum Concentration of SEP-380135 at Steady-State

    Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start7 Nov 2024
  3. Primary completion12 Sep 2025
  4. Study completion12 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07549581
Sponsor's protocol ID
384-201-00002
Status last verified
Apr 2026
First submitted
17 Apr 2026
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SEP-380135 in people with Schizophrenia and Major Depressive Disorder (MDD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cohorts: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) Leading to Trial Discontinuation (time frame: Up to Day 44). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07549581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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